The PERSEVERE Study

NCT06588634 | Recruiting DMC FDA Device

• 1 other identifier: 24-002
• Study Type: interventional
• Target: 200
• Locations: 6 countries
• Sites: 26

Brief Summary

Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Conditions

Pulmonary Embolism; Pulmonary Thromboembolism

Keywords

PE; Pulmonary Embolism; FlowTriever; CDT; Catheter Directed Thrombolysis; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• Composite clinical endpoint of the following adjudicated events:

  1. All-cause mortality 2. Cardiac arrest 3. Bailout to an alternative therapeutic strategy 4. Major bleeding 5. ECMO life support

  The earlier of initial hospital discharge or 7 days after randomization

Secondary Outcomes (12)

• All-cause mortality

  At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit

• Cardiac arrest

  At the earlier of initial hospital discharge or 7 days post randomization

• Bailout to an alternative therapeutic strategy

  At the earlier of initial hospital discharge or 7 days post randomization

• Major bleeding

  At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit

• ECMO life support

  7 days post-randomization

Study Arms (2)

FlowTriever

ACTIVE COMPARATOR

Device: FlowTriever System

Standard of Care

ACTIVE COMPARATOR

Procedure: Standard of Care

Interventions

FlowTriever System DEVICE

Mechanical thrombectomy for pulmonary embolism

FlowTriever

Standard of Care PROCEDURE

Standard of care treatment for pulmonary embolism

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at enrollment ≥18 years
• Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
• High-risk class of acute PE
• RV dysfunction, as defined RV/LV ratio ≥1.0
• Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

You may not qualify if:

• Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
• Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
• Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
• Recent stroke (\<14 days)
• Recent cranial or spinal surgery (\<14 days)
• Life-threatening active bleeding or hemorrhage into a critical area
• Known intracranial tumor
• End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
• Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
• Current participation in another drug or device study that may interfere with the conduct of this trial
• Ventricular arrhythmias refractory to treatment at the time of enrollment
• Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
• Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
• Subject was previously enrolled in this study

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (26)

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

Orlando Health Regional Medical Center

Orlando, Florida, 32806, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Northwell Health

Bay Shore, New York, 11706, United States

RECRUITING

SUNY, The University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Summa Akron

Akron, Ohio, 44304, United States

RECRUITING

UPHS Penn Health System

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

HCA Tristar/Centennial

Nashville, Tennessee, 37203, United States

RECRUITING

HCA Medical City Heart & Spine

Dallas, Texas, 75039, United States

RECRUITING

HCA Methodist Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Besançon University Hospital

Besançon, 25030, France

RECRUITING

Hopital Arnaud de Villeneuve, Montpellier

Montpellier, France

RECRUITING

CHU Nîmes Caremeau

Nîmes, France

RECRUITING

Hôpital Européen Georges-Pompidou, Paris

Paris, France

RECRUITING

Klinikum Chemnitz

Chemnitz, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

RECRUITING

Universitätsmedizin Mainz

Mainz, 55131, Germany

RECRUITING

Munich LMU

München, Germany

RECRUITING

Universitätsklinik Regensburg

Regensburg, Germany

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario La Paz Madrid

Madrid, 28046, Spain

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Royal Free Hospital London

London, United Kingdom

RECRUITING

Related Publications (1)

• Chopard R, Hobohm L, Barco S, Bangalore S, Giri J, Mahfoud F, Moriarty J, Rosenkranz S, Sharp A, Thiele H, Toma C, Tapson VF, Markovitz CD, Rosenberg SP, Konstantinides S, Meneveau N. Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. 2026 Apr;294:107331. doi: 10.1016/j.ahj.2025.107331. Epub 2025 Dec 24.

  PMID: 41453591 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nicolas Meneveau, MD PhD

  Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France

  PRINCIPAL INVESTIGATOR

• Stavros Konstantinides, MD PhD

  Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany

  PRINCIPAL INVESTIGATOR

• John M Moriarty, MD

  Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA

  PRINCIPAL INVESTIGATOR

• Jay Giri, MD, MPH

  Penn Medicine, Philadelphia, PA, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tine Devolder

CONTACT

+32 476 53 88 05; tine.devolder@inarimedical.com

Jen Foss

CONTACT

978-587-6598; jenifer.foss@stryker.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); DE (5); US (13); ES (2); CH (1); GB (1)